The present invention relates generally to medical devices, and more particularly to methods and apparatus for making connections between blood vessels or other adjacently situated anatomical or synthetic structures having hollow lumens or cavities formed therein.
In modern medical practice, it is often desirable to form connections between adjacent anatomical passageways, or between adjacent segments of a single anatomical passageway. The types of anatomical passageways between which such connections may be made include; blood vessels, vas deferens, fallopian tubes, intestines, lymphatic ducts, grafts, ventricular cavities of the heart or brain, etc.
Recently, applicant has devised certain in situ vascular bypass procedures wherein blood flow passageways (e.g., puncture tracts or interstitial tunnels) are formed between the lumens adjacently situated blood vessels (e.g., between an obstructed coronary artery and an adjacent coronary vein) to bypass a diseased, injured or obstructed segment of one blood vessel. These procedures have previously been described in U.S. patent application Ser. Nos. 08/730,327 and 08/730,496. Also, Provisional U.S. Patent Application Ser. No. 60/010,614 particularly describes certain minimally invasive vascular grafting procedures devised by applicant for by-passing an obstructed artery. In these grafting procedures, a tubular graft (e.g., a segment of an endogenous blood vessel or a tube graft formed of natural or synthetic material) is maneuvered into juxtaposition with the obstructed artery. One or more openings are formed in the graft and the adjacent artery. The openings formed in the graft are then connected to the openings formed in the artery, such that blood may flow between the graft and the artery.
Additionally, various procedures have been reported by others wherein implantable apparatus are used to connect or facilitate flow of bodily fluid between anatomical passageways (e.g., genitourinary ducts). One such procedure is described in U.S. Pat. No. 3,042,021 (Read) entitled BYPASS TYPE INSERT PLUG FOR BODY PASSAGEWAY.
To facilitate the connection of adjacently situated anatomical structures, as in the above-mentioned medical procedures, there exists a need in the art for the design and development of new connector apparatus which may be implanted, through transluminal catheters or probes, to form a secure connection between openings formed in adjacently situated anatomical structures and/or to maintain such openings in direct alignment and/or fluidic communication with each other.
The present invention provides apparatus for connecting or joining a first opening formed in a first anatomical structure of the type having a hollow inner space or lumen (e.g., a blood vessel, a hollow organ, a chamber of the heart, a vascular graft, etc.) with a second opening formed in a second anatomical structure which also has a hollow innerspace of similar type. In general, these connecting apparatus comprise a) a first engagement member which is engageable with the first anatomical structure, b) a second engagement member which is engageable with the second anatomical structure, and c) a connecting portion which extends or traverses between the first and second engagement members, and serves to hold the openings formed in the first and second anatomical structures in the desired alignment, typically, such that fluid may pass from one anatomical structure into the other.
Further in accordance with the invention, the connecting apparatus may be initially deployable in a radially compact state such that it may be advanced transluminally through the body to a desired implantation site, and is subsequently transitionable to a radially expanded configuration wherein the first engagement member will engage the first anatomical structure and the second engagement member will engage the second anatomical structure. Additionally or alternatively, the first and second engagement members may be initially deployed in non-operative positions (e.g., extending generally parallel to the longitudinal axis of the apparatus) to facilitate transluminal passage and/or placement of the apparatus at the desired implantation site. Thereafter, the first and second engagement members may be transitionable to a second configuration (e.g., an outwardly splayed configuration) such that the first and second engagement members will engage the first and second anatomical structures, as desired. In this manner, the apparatus may be self expanding or self splaying (e.g., formed of resilient or shape memory material) such that the radial expansion or transitioning of the engagement members will occur when surrounding constraint (e.g., constraint of a surrounding catheter wall) has been removed from the apparatus. Alternatively, the apparatus may be plastically deformable and provided with a pressure-exerting tool (e.g., a balloon) which will plastically deform the apparatus to cause the desired radial expansion and/or transitioning of the engagement members after the apparatus has been positioned in its desired implantation site.
Further in accordance with the invention, the engagement members may comprise wire loops, wire members, flanges, extensions, tongues, or any other suitable type of member which will embed into or otherwise engage the adjacent surface of an anatomical structure so as to hold the apparatus at its desired implantation site and/or to maintain the patency of the passageway as well as the length of the connection.
Still further in accordance with the invention, the connecting portion of the apparatus may comprise one or more elongate strands or members, a solid or perforated tube, or any other suitable connecting portion which will serve to link or connect the first and second engagement members and hold them at their desired spaced-apart distance. In some embodiments, the connecting portion may be elastic or biased so as to exert continual pulling force or retraction against the first and second engagement members. In other embodiments, the connecting portion may be rigid and non-elastic so as to remain at a fixed non-alterable length. Additionally, in some embodiments, the connecting portion may define a cylindrical or annular support member which will dilate, support or otherwise maintain any surrounding interstitial tissue in a desired configuration so as to prevent blockage or non-patency of the flow path formed between the first and second openings in the first and second anatomical structures.
Additionally, the connecting portion may be constructed to maintain a minimum passageway diameter between the openings in the first and second anatomical structures. Also, the connecting portion may be constructed to perform some surface modeling or customization of the surrounding tissue as by mechanical pressure exertion, application of a coating or chemical treatment, xenograft, emission of energy, etc. In this manner, the delivery catheter or delivery system used to facilitate implantation of the correct connector apparatus may by equipped with wires, or other energy transmitting members which are in contact with the connector apparatus and which will deliver energy into the connector apparatus, thereby using the connector apparatus as an energy-transferring member for causing deburring, enlargement, scarring, or other modification of the surrounding tissue with which the connector comes in contact. Examples of the types of energy which may be useable for this purpose include electrical energy, radiofrequency, ultrasound, radiation (e.g, beta, gamma, etc.), etc.
Still further in accordance with the invention, the connecting portion of the apparatus may be elastic, adjustable, telescoping, distendible or of accordion construction, etc., so as to adjust or conform to passageways of differing length. This aspect of the invention will allow a connector apparatus to be used for applications wherein the distance between the first and second openings in the first and second anatomical structures may vary and in each specific application, to maintain the first and second anatomical structures in relatively constant tension (i.e., constant force). Alternatively, for connector apparatus which do not incorporate such longitudinal elasticity, adjustability, telescoping, distensible or accordion configuration, the connector apparatus may be provided in a variety of different lengths and the operator may select the appropriate length of the connector apparatus prior to installation.
Still further in accordance with the invention, the leading edge of the apparatus may be a sharpened cutting edge or may be otherwise adapted to cut or sever tissue, such that the delivery and advancement of the apparatus through the openings in the anatomical structures and/or the passageway created therebetween may further serve to form such openings or passageway, or to enlarge, customize, model or otherwise alter the tissue with which it comes in contact.
Still further in accordance with the invention, there are provided connector apparatus having a connecting portion which comprises legs or members which penetrate through tissue surrounding the openings formed in the anatomical structures and/or any intervening tissue located therebetween, such that the connecting portion of the apparatus is embedded within the host tissue and is actually located outside of the channel or passageway formed between the first and second openings in the first and second anatomical structures.
Still further in accordance with invention, there are provided delivery systems and devices for delivering and implanting the connector apparatus of the present invention. These delivery apparatus and devices are typically incorporated into or mounted upon a transluminally advanceable catheter, and comprise a retractable sheath, inflatable balloon, push rod, alter-apposing slider sheaths, or rotatable members which operate to radially expand or advance the connector apparatus into its desired implantation position within the body.
These and other elements and objects of the present invention will be more fully understood and appreciated upon reading of the detailed description of preferred embodiments set forth herebelow, and studying of the accompanying drawings wherein the preferred embodiments are shown.
FIG. 1 is a partial longitudinal sectional view of two adjacently positioned blood vessels having a blood flow passageway formed therebetween, and a connector apparatus of the present invention implanted within such blood flow passageway to facilitate and maintain the desired side-to-side connection between the blood vessels.
FIG. 2 is a perspective view of a coil-type connector apparatus of the present invention.
FIG. 2xe2x80x2 is a perspective view of a modified coil-type connector apparatus of the present invention.
FIG. 2xe2x80x3 is a perspective view of another modified coil-type connector apparatus of the present invention having a tubular mid portion.
FIG. 2xe2x80x2xe2x80x3 is a perspective view of another coil-type connector apparatus of the present invention having a fused mid-portion.
FIG. 2xe2x80x3xe2x80x3 is a side elevtional view of a helical coil connector apparatus of the present invention which is biased to a longitudinally collapsed configuration.
FIG. 3 is a perspective view of a mesh type connector apparatus of the present invention.
FIG. 3xe2x80x2 is a perspective view of a mesh type connector apparatus of the present invention having optional engagement members formed on either end thereof.
FIG. 3xe2x80x3 is a perspective view of the mesh type connector apparatus of FIG. 3xe2x80x2 wherein the engagement members are self-splaying.
FIG. 3xe2x80x2xe2x80x3 is a perspective view of the mesh type connector apparatus of FIG. 3xe2x80x2 wherein the engagement members are pressure-splayable, and wherein the apparatus is shown in conjunction with a pressure-exerting balloon catheter which is useable to splay the engagement members at the desired implantation site.
FIG. 4 is a perspective view of a tube type connector apparatus of the present invention.
FIG. 4xe2x80x2 is a perspective view of a tube type connector apparatus of the present invention having optional engagement members formed on either end thereof.
FIG. 4xe2x80x3 is a perspective view of the tube type connector apparatus shown in FIG. 4xe2x80x2, wherein the engagement members are self-splaying.
FIG. 4xe2x80x2xe2x80x3 is a perspective view of the tube type connector apparatus shown in FIG. 4xe2x80x2, wherein the engagement members are pressure-splayable, and wherein the apparatus is shown in conjunction with a pressure-exerting balloon catheter which is useable to cause splaying of the engagement members at the desired implantation site.
FIG. 5 is a perspective view of a cylindrical connector apparatus of the present invention comprising a solid (non-perforated) tube member having optional engagement members formed on either end thereof.
FIG. 5xe2x80x2 is a perspective view of a non-hyperbolic, cylindrical connector apparatus wherein the engagement members are self-splaying.
FIG. 5xe2x80x3 is a perspective view of a cylindrical connector apparatus wherein engagement members are pressure-splayable, and wherein the apparatus is shown in conjunction with a pressure-exerting balloon-catheter which is usable to cause splaying of the engagement members at the desired implantation site.
FIG. 5xe2x80x2xe2x80x3 is a perspective view of a cylindrical connector apparatus wherein the tube member is formed of wire mesh having a multiplicity of openings or perforations formed therein, and multiple engagement members are formed on both ends of the tube member;
FIG. 5xe2x80x3xe2x80x3 is a perspective view of a cylindrical connector apparatus wherein the tube member is formed of wire mesh having a multiplicity of openings or perforations formed therein, and two (2) engagement members are formed on each end of the tube member, said engagement members being in direct alignment with one another;
FIG. 5xe2x80x2xe2x80x3xe2x80x3 is a perspective view of a cylindrical connector apparatus wherein the tube member is formed of a solid tube, and wherein engagement members comprising semi-circular wire projections are mounted on either end of the tube member;
FIG. 6 is a perspective view of a two-piece rivet-type connector apparatus of the present invention having a first rib-in-groove connection system formed thereon.
FIG. 6xe2x80x2 is a perspective view of an alternative two-piece rivet-type connector apparatus of the present invention having a tapered friction-fit engagement system formed thereon.
FIG. 6xe2x80x3 is a perspective view of another alternative two-piece rivet-type connector apparatus of the present invention having a second rib-in-groove or magnetic type engagement system formed thereon.
FIG. 7a is a top plan view of a first elastomeric connector apparatus of the present invention comprising a tubular mid-portion having elastomeric engagement members formed at either end thereof.
FIG. 7axe2x80x2 is a perspective view of the elastomeric connector apparatus of FIG. 7a. 
FIG. 7b is a top plan view of another elastomeric connector apparatus of the present invention comprising a tubular mid portion having a non-circular lumen and engagement flanges formed at either end thereof.
FIG. 7bxe2x80x2 is a perspective view of the connector apparatus shown in FIG. 7b. 
FIG. 7c is a perspective view of a connector apparatus of the present invention comprising an elastomeric body having wire support members formed therein.
FIG. 7d is a perspective view of a wire connector apparatus of the present invention.
FIG. 7dxe2x80x2 is a perspective view of the wire connector apparatus of FIG. 7d having a cylindrical elastomeric or fabric sleeve formed thereon.
FIG. 7dxe2x80x3 is a perspective view of another wire connector apparatus formed of two of the connector apparatus of FIG. 7d, coupled together to form a singular apparatus.
FIG. 8 is a perspective view of a sinusoidal wire connector apparatus of the present invention in a flattened configuration, prior to fabrication into its desired final configuration.
FIG. 8a is a perspective view of the sinusoidal wire connector apparatus of FIG. 8 following fabrication of into its desired final configuration, and showing the apparatus in a preferred implantation position forming a connection between adjacent tubular anatomical conduits.
FIG. 9 is a perspective view of a triplet coil type connector apparatus of the present invention, showing the apparatus in a preferred implantation position forming a connection between adjacent tubular anatomical conduits.
FIG. 10 is a longitudinal sectional view of a flanged tube connector of the present invention in a preferred implantation position forming a connection between adjacent tubular anatomical conduits.
FIG. 10a is a perspective view of a segment of tubing which has been precut for fabrication into the flanged tubular connector apparatus of FIG. 10.
FIG. 10b is a side elevational view of the pre-notched segment of tubing shown in FIG. 10a. 
FIG. 11a is a perspective view of a first embodiment of a flanged roll-up connector apparatus of the present invention.
FIG. 11b is a perspective view of a second embodiment of a flanged roll-up connector apparatus of the present invention.
FIG. 11c is a perspective view of a flanged cylindrical connector apparatus of the present invention.
FIG. 12 is a perspective view showing the manner in which any of the connector apparatus of the present invention may be modified to form a non-perpendicular connection between adjacent anatomical structures.
FIG. 13 is a perspective view of a segment of myocardium showing an alternative application of the connector apparatus of the present invention to form a connection between a coronary blood vessel and a chamber of the heart.
FIG. 14a is a schematic showing of a retractable sheath type delivery catheter useable to deliver connector apparatus of the present invention.
FIG. 14b is a schematic showing of an inflatable balloon type delivery catheter useable to deliver connector apparatus of the present invention.
FIG. 14c is a schematic showing of a push rod type delivery catheter useable to deliver connector apparatus of the present invention.
FIG. 14d is a schematic showing of an alter-apposing slider sheath type delivery catheter useable to deliver connector apparatus of the present invention.
FIG. 14e is a schematic showing of a rotatable delivery catheter useable to deliver and implant connector apparatus of the present invention.
FIG. 15a is a showing of a two-piece connector apparatus as described and claimed in parent application Ser. No. 08/730,327, modified to illustrate the manner in which the connecting portion of the connector apparatus may protrude through tissue and lay outside of the passageway which has been formed between the adjacent anatomical structures.
FIG. 15axe2x80x2 is an exploded view of the connector apparatus shown in FIG. 15a.